Fact Sheet
COVID-19 Analytics
Manage Risk Minimize Impact
elluminate® COVID-19 Analytics help sponsors proactively manage the impact of COVID-19 on trial operations, data quality and patient safety for the duration of the pandemic. COVID-19 Analytics provide clinical trial managers and data managers with visualizations that enable them to quickly take action including those recommended in the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.1 The visualizations provide real-time information allowing trial managers to focus on those participants most likely experiencing COVID-19 related symptoms and to take actions recommended in the FDA guidance.
Monitor for Impacts Per FDA Guidance Which patients have missed visits that may require “…specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19). This information, summarized in the
clinical study report, will be helpful to the sponsor and FDA.” 1 “Trial participants [who] may not be able to come to the investigational site for protocol-specified visits,” allowing sponsors to evaluate “whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including
local labs or imaging centers) could be implemented when necessary and feasible,” 1 “Trial participants who no longer have access to investigational product or the investigational site may need additional safety monitoring (e.g. withdrawal of an active investigational treatment)...” 1